SUPPLY CHAIN ARTICLES

  • Plasmid Production: 3 Key Takeaways For mRNA Manufacturing

    Following my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid. 

  • Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control

    Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.

  • Assessing Quality Of mRNA Vaccines: Key Considerations

    To address the need for standards for mRNA vaccines, the United States Pharmacopeia (USP) has convened vaccine experts to identify important quality attributes and to propose test methods that can be used to assess mRNA vaccine products. This article shares those CQAs and analytical procedure tips.

  • What Violin Making Can Teach Us About mRNA Therapeutic Quality

    Managing the mRNA supply chain and working in mRNA process development may not look anything like the work a luthier does to hew an instrument from an ancient spruce tree. But violin craftmanship actually serves as a fantastic metaphor for the challenging work the mRNA therapeutics space is tackling in sourcing and qualifying raw materials and optimizing the critical IVT reaction.

  • 4 Risk Mitigation Strategies For mRNA Production

    Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.

  • The Price Is… Almost Right: mRNA Edition! COGS Reduction Strategies

    The following article will outline the current state of COGS in the mRNA industry and the work he and his colleagues undertook to more effectively utilize raw materials. But heaven forbid this be your normal conference panel write-up. No, below I share Parrella’s insights, but in the form of a never-before released episode of The Price is Right…or perhaps more fittingly given the state of the industry today, this spectacle is more aptly titled: The Price is…Sort Of, Almost, Not Quite Right! 

SUPPLY CHAIN VIDEOS

Together, this Advancing RNA panel briefly addresses the ongoing rise of synthetic pDNA, sharing the current benefits and limitations of working with this technology for plasmid production today.

While we can make lots of mRNA at a smaller scale, when it comes to scaling up to kg quantities of mRNA, our current batch processes leave a lot to be desired. Together, Stu Sundseth of Tune Therapeutics and Christian Dohmen of Ethris unpack the biggest barriers to scaling IVT to achieve the desired yield and quality of mRNA, offering their take on how the field is innovating to overcome these issues. 

In this Advancing RNA Live clip, CMC consultant Sujit Jain unpacks the levels of maturity he’s observed in process and analytical development, as well as supply chain. While vaccines and liver-targeting therapeutics boast what we can call a reproducible platform today, targeted LNP therapies introduce a handful of scale-up sensitivities and characterization hurdles.

Unlock the full potential of your pDNA purification with advanced chromatography solutions and resins that tackle high viscosity and impurities to ensure superior quality and yield.

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